BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 3841165 · Received February 26, 2014

    Report

    Report Number
    1035166-2014-00006
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    November 4, 2013
    Report Date
    February 25, 2014
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS CAPPED, THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO BECOMES AVAILABLE. NO ALLEGATION OUR LEAD FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LEAD FRACTURE IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    ON (B)(6)2014, THE CUSTOMER REPORTED ACCORDING TO THE SALES REPRESENTATIVE THIS LEAD WAS CAPPED ON (B)(6) 2013 BECAUSE IT WAS FRACTURED. THERE WERE NO OTHER ADVERSE PATIENT EVENTS REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 11 YEARS, 8 MONTHS. UPDATED INFO REC'D FROM THE CUSTOMER ON (B)(6) 2014, THE CUSTOMER REPORTED ACCORDING TO THE SALES REPRESENTATIVE THIS LEAD WAS CAPPED ON (B)(6) 2013 BECAUSE IT WAS FRACTURED. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118683 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY 48 PSBV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR